Cellectis' lasme-cel gets FDA RMAT designation for r/r B-ALL

Cellectis announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy candidate. This designation is for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), recognizing the potential to address unmet medical needs. The RMAT designation is supported by promising efficacy and a manageable safety profile from Phase 1 BALLI-01 data, with final data to be presented at the 2026 EHA Congress. The pivotal Phase 2 BALLI-01 trial is currently open for enrollment.